Contact information
Type
Scientific
Primary contact
Prof W J Fokkens
ORCID ID
Contact details
Academic Medical Centre (AMC)
Department of Otorhinolaryngology
Room A2-234
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 3789
W.J.Fokkens@amc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR719
Study information
Scientific title
Acronym
ViMiNa
Study hypothesis
Xylometazoline nasal spray relieves vasoconstriction in the nasal mucosa, which will be assessed and visualised using sidestream dark-field (SDF) imaging.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Nasal disorder
Intervention
The microcirculation of the nasal mucosa of healthy controls will be assessed using a non-invasive probe, diameter 0.5 cm, which will be placed in the nasal cavity, twice for a period of approximately 10 minutes. Images will be recorded to make off-line analysis possible. In between the two periods of recording or measuring, the healthy volunteers will get a provocation with xylometazoline nasal spray or placebo. After a few minutes, a second measurement will be taken to assess possible differences in the microcirculation.
Intervention type
Drug
Phase
Not Specified
Drug names
Xylometazoline
Primary outcome measures
The following parameters will be used to assess the microcirculatory reaction after provocation:
Flow in the capillary, venules and arterioles can be scored semi-quantitatively or quantitatively:
1. Semi-quantitative scoring:
0 = no flow
1 = intermittent flow
2 = sluggish flow
3 = continuous flow
2. Quantitative scoring: velocity, flow, diameter, length, density
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/07/2006
Overall trial end date
01/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with active allergic rhinitis, idiopathic rhinitis, chronic rhinosinusitis or nasal polyps
2. Males or females aged over 18 years; no maximum age
3. Approval from the patient's physician
4. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Smoker
2. Severe cardiac or pulmonary disorder
3. Peripheral vascular disease
4. Medication: systemic alpha-blockers, corticosteroids (local and systemic), any local nasal treatment, bronchodilatory inhalation medication for pulmonary diseases >1000 µg/day
5. Cystic fibrosis, immotile cilia syndrome, Rendu-Osler-Weber disease, vasculitis
6. Cocaine and/or alcohol abuse
Recruitment start date
01/07/2006
Recruitment end date
01/12/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (The Netherlands)
Sponsor details
Department of Otorhinolaryngology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary